FDA Approves New Duodenoscope That May Help Reduce Infections

Over the past several years, a number of hospitals have reported infectious disease outbreaks linked to contaminated duodenoscopes. These devices are most commonly used to diagnose and treat health problems associated with the liver, bile ducts, and pancreas.

New Duodenoscope Design Intended to Reduce Risk of Infections

Earlier this year, the FDA warned that the Pentax duodenoscope could increase the risk of patient infections. At the time, the FDA reported that “[c]racks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.”

On September 20, 2017, the FDA approved a new version of the Pentax duodenoscope, the “Pentax ED34-i10T”, that also manufactured by Japanese device maker Pentax. This design is the “first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing.” The product is called the “Pentax ED34-i10T”.

“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

The disposable cap provides access to tiny crevices in the tip of the scope—areas that in the past have proved difficult to clean. Because duodenoscopes are reusable devices, any bacteria left in the scope may be transferred from one patient to another in surgery if it is not properly cleaned and disinfected between uses.

Will this design truly help prevent the serious infections associated with previous duodenoscopes? It’s unclear so far. Lawrence Muscarella, a hospital-safety consultant in Pennsylvania, told the Los Angeles Times that the new scope would probably reduce infection risk, “but [he’s] not sure by how much.”

New Duodenoscope Design Intended to Reduce Risk of Infections

Last year, the U.S. Health, Education, Labor and Pensions Committee reported that duodenoscope-related infections had been linked with serious, sometimes life-threatening antibiotic-resistant infections worldwide.

In February 2015, the Ronald Reagan Medical Center reported a superbug outbreak that involved the Olympus closed-channel duodenoscopes. Between 2010 and 2015, as many as 350 patients at 41 medical facilities in the U.S. were infected or exposed to tainted scopes, and there are likely many more that had not been reported. The following year, Olympus recalled its TJF-Q180V duodenoscope to update the design to help reduce the risk of infection.